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Use of Human Subjects Policy

Approved By and Date:

Board of Trustees

04-10-2014

Executive Leadership Team

11-25-2013

ICORE

11-20-2013

The purpose of the Stanly Community College (SCC) Use of Human Subjects Policy is to protect the rights and welfare of human subjects through the review of educational practices and potential research projects. SCC encourages and supports the scholarly endeavors of its students, faculty, and staff. When such scholarly work involves the use of human subjects for training and/or data collection and analysis, the proposed educational practices and research projects will be reviewed to ensure that:

The rights and welfare of human subjects are protected

Risks have been considered and minimized

Potential for benefit has been identified and maximized

All human subjects only volunteer to participate in research and/or training after being provided with legally effective informed consent

Any research and educational practice is conducted in an ethical manner and in compliance with established standards, including handling all private information with confidentiality

Use of Human Subjects Procedures

Approved By and Date:

Executive Leadership Team

11-25-2013

ICORE

11-20-2013

1. HUMAN SUBJECTS IN EDUCATION AND TRAINING

Laboratory hands-on training is an essential element in various SCC educational programs. Students must be proficient with live client and/or patient care techniques. Therefore, these skills must be practiced on fellow students under the supervision of program faculty. Safety and respect for each other is of vital importance. In order to protect the well-being of surrogates and to ensure that participating students are participating as a human subject on a voluntary basis, the following are required:

A. Each educational program that requires the use of human subjects in the training curriculum will ensure that participating students are informed of the details and degree to which they are expected to participate as human subjects. Each program of this type will also require each participating student to sign an informed consent or written authorization for use as a human subject prior to participation as a human subject.

B. Students will not be allowed to apply modalities or procedures to human subjects until they have demonstrated proper operation of the equipment and are approved to work with human subjects by an appropriate qualified instructor. This approval will be documented in student or class records and kept by the program head or designee.

2. HUMAN SUBJECTS IN RESEARCH

A. Definition – Research involving human subjects is defined as any systematic investigation

designed to develop or contribute to generalizable knowledge that involves the

investigation of one or more living individuals about whom the investigator (whether

(45 CFR 46). SCC will consider the approval of research projects that either do not include human subject research or are considered “exempt” from the required review of an IRB. All research efforts that potentially include the use of SCC employee or student information will be reviewed to determine:

i. whether the research involves human subjects

ii. whether the research is considered “exempt” from the federal requirement of review

by an Institutional Review Board (IRB)

iii. the level of involvement of SCC Institutional Research personnel in the project

iv. approval of the project to proceed with or without modifications if the research

project is determined to be “exempt” from IRB review requirements

v. disapproval of the project if the research is determined to be “non-exempt” from IRB

review requirements

D. Exempt Human Subject Research

Investigators cannot self-determine whether the proposed research is exempt from IRB

review. This is to be determined by the Director of Institutional Research and Planning,

who will follow the guidelines set forth in 45 CFR 46. If the complexity of the request or

proposal requires additional expertise, a Research Review Committee will be formed by

the Director. The Committee will review the proposal and make recommendations to the

Director. Examples of exempt research (i.e. research that may be approved by SCC)

ii. research involving the use of educational tests if the information taken from these sources is recorded in such a manner that the subjects cannot be identified either directly or indirectly

iii. research involving the collection or study of existing data, documents, records,

pathological specimens, or diagnostic specimens if these sources are publicly

available and if the information is recorded by the investigator in such a manner

that subjects cannot be identified directly or indirectly

iv. research involving the observation of public behavior or research involving survey or

interview procedures EXCEPT when:

- data are recorded in a manner enabling identification of subjects and the subject’s responses, if they were to become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing,

- the research deals with sensitive aspects of the subject’s behavior such as illegal

conduct, drug or alcohol use, sexual behavior, or

- the research deals with study participants who are likely to be vulnerable to coercion or undue influence, such as minors under the age of 18 (45 CFR 46 Subpart D), prisoners (45 CFR 46 Subpart C), pregnant women (45 CFR 46 Subpart B), persons with mental disabilities, or person whose economic status would leave them susceptible to coercion.

E. Non-Exempt Human Subject Research

When the proposed research is not applicable to the above described “exempt” categories, and consequently receives the “non-exempt” designation, SCC will deny the project. This includes research that falls under the exceptions listed in Section 2.D.d above. Investigators are welcomed to modify the project so that non-exempt human subject research is not included, and then reapply for SCC authorization.

F. Research Review Committee

i. The purpose of the Research Review Committee is to review research requests and proposals when the complexity of such projects requires a collaborative team of professionals with relevant expertise to determine whether research is considered exempt of the requirement of an IRB.

ii. The Committee will be comprised of at least 5 and no more than 7 research and

subject matter professionals, who will be briefed on the applicable federal guidelines.

G. Degree of SCC Involvement

When investigators request the use of existing data, which may only be accessible to specific SCC personnel, it becomes necessary for SCC personnel to assist in the retrieval of this data. It is important to note that the role of SCC personnel will be restricted to the extract of such data for the investigator. Additional research-related tasks such as data analysis, statistical testing and graphic presentations will not be performed by SCC personnel. If the data request is unclear, the investigator may be required to work with his or her supervisor or educational advisor to better communicate the information requested.

H. Informed Consent

Each approved research project that requires intervention and/or interaction with the human subject will require that each subject sign an informed consent. The language of this form must indicate:

i. that participation in the project is voluntary

ii. that participation in the project is independent of course grades and/or other indicators of student success

iii. a description of the purpose of the project and the details of participation

iv. assurance that students, faculty, or staff involved in the research project will not be

identified when the findings of that project are published

v. an explanation of whom to contact for answers to pertinent questions about the research

and research subjects’ rights, and whom to contact in the event of a research-related injury

to the subject

vi. a list of possible risks and/or benefits of participating as a subject of research